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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; LOCKING SCREW
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ULRICH GMBH & CO. KG UCENTUM; LOCKING SCREW Back to Search Results
Model Number CS 3801-01
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 10/12/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Ulrich medical gmbh (manufacturer) is submitting this report for both ulrich medical gmbh and ulrich medical usa (importer).Exemption # e2014011.
 
Event or Problem Description
Two locking screws disassociated postoperatively from the pedicle screws and had to be replaced.
 
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Brand Name
UCENTUM
Common Device Name
LOCKING SCREW
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, baden-württemberg 89081
GM  89081
MDR Report Key8018842
Report Number9612420-2018-00016
Device Sequence Number16488923
Product Code NKB
UDI-Device Identifier04052536078646
UDI-Public4052536078646
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K123717
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Model NumberCS 3801-01
Device Catalogue NumberCS 3801-01
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/17/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/12/2018
Initial Report FDA Received Date10/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age40 YR
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